Job Title: Manager, Biostatistics and Statistical Programming
The function of the Manager, Biostatistics & Statistical Programming is to supervise and manage the daily operations of the biostatisticians and SAS® programmers. This entails the management of activities related to data analysis and generation of the corresponding output (tables, listings, figures, and electronic datafiles). This position reports to the VP, Scientific Affairs.
- Manage the day-to-day operations of the biostatisticians and statistical analysis programmers.
- Ensure activities of this team are consistent with the companies goals/objectives and that efficient/effective procedures are maintained within the department.
- Interact with the Project Management, Clinical team, Scientific Affairs team, and Clinical Data Management team members to negotiate timelines and responsibilities for study deliverables.
- Provides advice for sample size requirements, dosing schemes and data analysis.
- Reviews and contributes to the development of statistical/data analysis plans (SAP/DAP).
- Perform and/or verifies statistical analysis of data generated in Phase I-IV clinical trials.
- Provide recommendations and leadership regarding SAS® analysis datasets and CDISC submission datasets.
- Create new and/or improve existing SAS® programs used to perform data analysis, generate listings, tabulations, graphical presentations and summary statistics to support regulatory submissions.
- Validates statistical programs and SAS® applications for Phase I-IV and BA/BE studies.
- Lead the team in documenting data, programming information and statistical analyses in accordance to Standard Operating Procedures (SOPs) and guidelines.
- Responsible for communicating directly or through designated personnel with Regulatory Agencies on behalf of the company
- Responsible for acquiring, maintaining and training of staff of national and international guidelines relating to statistical analysis and statistical programming standards.
- Ensure team compliance with appropriate SOPs, Regulatory Authorities, Good Clinical Practice (GCP) and ICH guidelines.
- Master or Doctoral degree in Mathematics and/or Statistics
- 5 years related experience
- Advanced SAS® programming skills
- In depth knowledge of statistical software (SAS®) is required.
- Ability to lead project teams and provide in depth statistical and programming expertise internally and to clients
- Some travel in Canada and internationally, as required.
If you meet the above qualifications and are interested in learning more about this opportunity, please click "Apply" or send your resume directly to Bryan Forrest at firstname.lastname@example.org